Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003325

Enrollment

515

Registered

2003-01-27

Start date

1999-12-31

Completion date

Unknown

Last updated

2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar Cancer

Keywords

stage I vulvar cancer, stage II vulvar cancer, squamous cell carcinoma of the vulva

Brief summary

RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva. PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.

Detailed description

OBJECTIVES: * Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva. * Determine the location of the sentinel node in these patients. OUTLINE: Patients receive injection(s) of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins. Preoperative lymphoscintigraphy is also performed. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until recurrence. PROJECTED ACCRUAL: A total of 40-630 patients will be accrued for this study within 2-6 years.

Interventions

PROCEDURESentinel lymph node mapping

Sentinel lymph node mapping

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg * Tumor size must be 2-6 cm * No recurrent disease * Prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed * No tumor extending into the urethra, anus, vagina, rectum, or bladder * No grossly suspicious or inflamed groin nodes on physical exam * No grossly infected primary tumors PATIENT CHARACTERISTICS: Age: * Any age Performance status: * GOG 0-3 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other invasive malignancy within the past 5 years except non-melanomatous skin cancer * No known hypersensitivity to phenylethane compounds PRIOR CONCURRENT THERAPY: * No prior cancer therapy that contraindicates therapy in this study Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No prior groin dissection

Design outcomes

Primary

Measure	Time frame
Predictive value of negative sentinel lymph nodes in vulvar cancer patients	at time of surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026